FDA.reportPublic FDA data

hydrocortisone 25 MG/ML Topical Cream [Proctosol]

RxCUI
1540356
RxNorm name
hydrocortisone 25 MG/ML Topical Cream [Proctosol]
Display name
PROCTOSOL (Topical)
Full name
hydrocortisone 25 MG/ML Topical Cream [Proctosol]
Term type
SBD
Status
Active
Strength
2.5%
Dose form
Cream
Route
Topical
Updated
2026-09-29 04:12:07

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
072014
Active start
072014
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
hydrocortisone25 MG / 1 MLhydrocortisonehydrocortisone

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Cream316982

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
hydrocortisone5492

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRProctosol 25 MG/ML Topical Cream1NAMES
RxNorm Namehydrocortisone 25 MG/ML Topical Cream [Proctosol]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI15403561CODES
MMSL_CODEBD16331CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
10631-407-0110631-407Proctosol-HC HydrocortisoneSun Pharmaceutical Industries, Inc.ANDA088799
72162-2165-272162-2165Proctosol-HC HydrocortisoneBryant Ranch PrepackANDA088799

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA08879910631-407Proctosol-HC HydrocortisoneANDASun Pharmaceutical Industries, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
10631040701rxnav_ndcsyes
72162216502rxnav_ndcsyes
50090154900rxnav_historical
68788051102rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proctosol-HCHYDROCORTISONEBryant Ranch Prepack68e177fd-87aa-45f3-a380-0d092abdb77d2025-11-05Adverse reactionsExact identifier
ndc (package): 72162-2165-2
ndc (product): 72162-2165
ndc11 (package): 72162216502
rxcui: 1540356
Proctosol-HCHYDROCORTISONESun Pharmaceutical Industries, Inc.565284e7-4994-486b-8267-18bd166655ac2025-07-02Adverse reactionsExact identifier
ndc (package): 10631-407-01
ndc (product): 10631-407
ndc11 (package): 10631040701
rxcui: 1540356

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
68e177fd-87aa-45f3-a380-0d092abdb77dProctosol-HC 2.5 % Topical Cream [PSN] · hydrocortisone 25 MG/ML Topical Cream [Proctosol] [SBD] · Proctosol 25 MG/ML Topical Cream [SY] · Proctosol-HC 2.5 % Topical Cream [SY]4101Proctosol-HC ® 2.5% (Hydrocortisone Cream, USP)20251105
565284e7-4994-486b-8267-18bd166655acProctosol-HC 2.5 % Topical Cream [PSN] · hydrocortisone 25 MG/ML Topical Cream [Proctosol] [SBD] · Proctosol 25 MG/ML Topical Cream [SY] · Proctosol-HC 2.5 % Topical Cream [SY]47Proctosol-HC ® 2.5% (Hydrocortisone Cream, USP)20250702

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
68e177fd-87aa-45f3-a380-0d092abdb77dProctosol-HC ® 2.5% (Hydrocortisone Cream, USP)Bryant Ranch Prepack20251105
565284e7-4994-486b-8267-18bd166655acProctosol-HC ® 2.5% (Hydrocortisone Cream, USP)Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.20250702
68e177fd-87aa-45f3-a380-0d092abdb77dProctosol-HC ® 2.5% (Hydrocortisone Cream, USP)Bryant Ranch Prepack20231207
61065a81-abd2-4fd6-8361-4570d5d0d8faNational Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS02BACorticosteroidsATC1-4hydrocortisone
ATCC05AACorticosteroidsATC1-4hydrocortisone
ATCA07EACorticosteroids acting locallyATC1-4hydrocortisone
ATCA01ACCorticosteroids for local oral treatmentATC1-4hydrocortisone
ATCS01BACorticosteroids, plainATC1-4hydrocortisone
ATCD07AACorticosteroids, weak (group I)ATC1-4hydrocortisone
ATCD07XACorticosteroids, weak, other combinationsATC1-4hydrocortisone
ATCS01CBCorticosteroids/antiinfectives/mydriatics in combinationATC1-4hydrocortisone
ATCH02ABGlucocorticoidsATC1-4hydrocortisone
FDASPLN0000175576CorticosteroidEPChas_epchydrocortisone
MEDRTD006854HydrocortisoneCHEMhas_ingredienthydrocortisone
MEDRTD000312Adrenal Hyperplasia, CongenitalDISEASEmay_treathydrocortisone
MEDRTD000309Adrenal InsufficiencyDISEASEmay_treathydrocortisone
MEDRTD003093Colitis, UlcerativeDISEASEmay_treathydrocortisone
MEDRTD003877Dermatitis, ContactDISEASEmay_treathydrocortisone
MEDRTD003881DermatomycosesDISEASEci_withhydrocortisone
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrocortisone
MEDRTD005148Facial DermatosesDISEASEmay_treathydrocortisone
MEDRTD005533Foot DermatosesDISEASEmay_treathydrocortisone
MEDRTD006229Hand DermatosesDISEASEmay_treathydrocortisone
MEDRTD006484HemorrhoidsDISEASEmay_treathydrocortisone
MEDRTD007249InflammationDISEASEmay_treathydrocortisone
MEDRTD007868Leg DermatosesDISEASEmay_treathydrocortisone
MEDRTD011538Pruritus AniDISEASEmay_treathydrocortisone
MEDRTD012216Rheumatic DiseasesDISEASEmay_treathydrocortisone
MEDRTD012536Scalp DermatosesDISEASEmay_treathydrocortisone
MEDRTD012769ShockDISEASEmay_treathydrocortisone
MEDRTD012876Skin Diseases, ParasiticDISEASEci_withhydrocortisone
MEDRTD017193Skin Diseases, ViralDISEASEci_withhydrocortisone
MEDRTD013224Status AsthmaticusDISEASEmay_treathydrocortisone
MEDRTD014382Tuberculosis, CutaneousDISEASEci_withhydrocortisone
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moahydrocortisone
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moahydrocortisone
MEDRTN0000008327Carbohydrate Metabolism AlterationPEhas_pehydrocortisone
MEDRTN0000010253Decreased Capillary PermeabilityPEhas_pehydrocortisone
MEDRTN0000010248Decreased Fibroblast MigrationPEhas_pehydrocortisone
MEDRTN0000008645Decreased Glucocorticoid SecretionPEhas_pehydrocortisone
MEDRTN0000008681Decreased Leukotriene ActivityPEhas_pehydrocortisone
MEDRTN0000008700Decreased Lysosomal FunctionPEhas_pehydrocortisone
MEDRTN0000010246Decreased Polymorphonuclear Leukocyte MigrationPEhas_pehydrocortisone
MEDRTN0000008834Decreased Prostaglandin ActivityPEhas_pehydrocortisone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pehydrocortisone
MEDRTN0000009004Decreased Thromboxane ActivityPEhas_pehydrocortisone
MEDRTN0000009739Lipid Metabolism AlterationPEhas_pehydrocortisone

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH25 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA088799
NAMESPrescribable SynonymProctosol-HC 2.5 % Topical Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon